A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in Healthy Participants
Crinetics Pharmaceuticals Inc.
Summary
This study aims to evaluate the impact of strong CYP3A4 induction on the pharmacokinetics (PK) of atumelnant, as well as the effect of atumelnant on CYP3A4, P-gp, and MATE1/2-K substrates in healthy participants.
Description
This is a Phase 1, open-label, two-Cohort Study to assess the effect of a strong CYP3A4 inducer on the pharmacokinetics of atumelnant and the effect of atumelnant on the pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in healthy participants. Approximately 20 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 1. Approximately 26 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 2.
Eligibility
- Age range
- 19–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit. 2. BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit. 3. Is willing and able to comply with all study procedures and restrictions, including fasting and consumption of protocol-specified standardized meal for required study measurements; inpatient admission; follow-up contact; receipt of rescue therapy, if necessary; abstinence from tobacco, alcohol, drugs, and from strenuous unaccustomed exercise and sports (defined as greater…
Interventions
- DrugAtumelnant
Atumelnant, tablets
- DrugCarbamazepine
CYP3A4 inducer
- DrugMidazolam
CYP3A4 substrate
- DrugDigoxin
P-gp substrate
- DrugMetformin
MATE1/2-K substrate
Location
- Crinetics Study SiteLincoln, Nebraska